Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study (Isotoxic-IMRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836692
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
Cancer Research UK
British Lung Foundation
Sheffield Teaching Hospitals NHS Foundation Trust
Belfast Health and Social Care Trust
The Leeds Teaching Hospitals NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Royal Marsden NHS Foundation Trust
East and North Hertfordshire NHS Trust
Information provided by (Responsible Party):
Prof Corinne Faivre-Finn, The Christie NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE April 12, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date October 31, 2018
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
The number of participants treated with isotoxic RT (to dose >60 Gy EQD2) using IMRT & hyperfractionated accelerated RT. [ Time Frame: Stage 1 (12 months) - after 19 patients have been treated with isotoxic IMRT ]
Radiotherapy treatment plans & OAR tolerance doses will be analysed to assess the feasibility of delivering the proposed treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
  • The number of participants from the study population who are suitable to receive isotoxic IMRT treatment. [ Time Frame: 12 months ]
    Stage 1 - if 13/19 patients can be planned to a dose of >60 Gy EQD2 the study will proceed to stage 2 and recruit a further 16 patients. Assessed via RT planning data.
  • The number of participants treated with isotoxic IMRT who experience grade 3+ pulmonary toxicity [ Time Frame: 12 months ]
    Stage 1 - if <3/19 participants experience grade 3+ acute pulmonary toxicity the study will proceed to stage 2 and recruit a further 16 patients. Assessed via toxicity data.
  • The number of participants treated with isotoxic IMRT who experience acute grade 3+ non haematological toxicity & other late toxicities [ Time Frame: 12 months ]
    To assess via toxicity data, the number of patients who experience grade 3+ non haematological toxicities and other late toxicities
  • Number of participants whose disease is controlled locally & overall survival rates [ Time Frame: Follow up visits every 4 months for 2 years & then 6 monthly for up to 5 years ]
    After completion of radiotherapy treatment regular follow up will continue and data on long term toxicity, local control and survival will be collected.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
Official Title  ICMJE Isotoxic Intensity Modulated Radiotherapy (IMRT) in Stage III Non Small Cell Lung Cancer (NSCLC) - A Feasibility Study
Brief Summary

This study is for patients having a course of chest radiotherapy treatment after receiving chemotherapy for the treatment of non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.

In this study, we will investigate:

  • whether giving a more targeted and individualised type of chest irradiation or radiotherapy to the lung tumour (known as Isotoxic IMRT), is practical and whether it causes side effects which can be tolerated
  • whether this new method of delivering the radiotherapy can reduce the risk of the tumour in the lung recurring or progressing
  • whether survival can be improved by using this new radiotherapy method

The dose of chest irradiation will be calculated specifically to suit patient's body shape, the position of the lung cancer, and how close healthy tissues are to the tumour. Radiotherapy will be delivered twice a day over a maximum period of 4.5 weeks. The duration of treatment will vary individually according to the delivered dose to the tumour area.

Detailed Description

Background:

Approximately 12,000 patients are diagnosed with stage III NSCLC in the UK each year and their survival is ~15% at 5 years. As the majority of patients are not suitable for the gold standard treatment (concurrent chemo-radiotherapy (CTRT), novel strategies integrating radiotherapy (RT) technological advances and radiobiological knowledge need to be evaluated in patients treated with the alternative treatment option, sequential CTRT. There is solid evidence that improving local control in lung cancer leads to increased survival. Strategies to improve local control in stage III NSCLC include dose escalation and individualisation which are limited by the dose delivered to surrounding normal tissues. We hypothesise that this will be facilitated by the use of IMRT.

Objectives:

To demonstrate the feasibility of delivering isotoxic RT using IMRT and hyperfractionated accelerated RT in stage III NSCLC patients who are not suitable for concurrent CTRT.

Endpoints:

Primary endpoint: Delivery of isotoxic IMRT to dose >60 Gy EQD2 (total biologically equivalent in 2 Gy fraction).

Secondary endpoints: Estimation of the suitability for lung isotoxic IMRT, estimation of proportion of patients with acute grade 3+ non haematological toxicity, estimation of late toxicity, estimation of local control/overall survival and development of a robust Quality Assurance (QA) process for lung IMRT.

Design:

Prospective multicentre, non-randomised feasibility study with early stopping rules.

35 patients will be recruited in this prospective multicentre feasibility study. Stopping rules are in place to ensure the safety of patients. We estimate that this regimen would be of added value to a national randomised phase II trial if 80% of the patients can be planned to a dose >60 Gy EQD2.

Intervention:

Patients with stage III NSCLC, PS 0-2, not suitable for concurrent CTRT, will be treated with individualised doses of radiation based on pre-specified normal tissue doses (spinal cord, brachial plexus, lung tissue, heart and great vessels/proximal bronchial tree). Radiotherapy will be delivered twice-daily over a maximum period of 4.5 weeks using IMRT and the dose of radiation will be increased until one or more of the organs at risk tolerance or the maximum dose of 79.2 Gy is reached.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE Radiation: Intensity Modulated Radiotherapy treatment
Intensity Modulated Radiotherapy treatment
Study Arms  ICMJE Experimental: Thoracic radiotherapy
Intensity Modulated Radiotherapy treatment (delivered twice daily on consecutive weekdays over 4.5 weeks)
Intervention: Radiation: Intensity Modulated Radiotherapy treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2016)
38
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2013)
35
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed NSCLC
  • Inoperable Stage III disease (T3N1-3, any T4, any N2 -3) confirmed by PET scanning, mediastinoscopy or thoracoscopy
  • Patients treated with at least 2 cycles of platinum based induction chemotherapy and able to start radiotherapy within 5 weeks of the last cycle of chemotherapy
  • Tumour judged inoperable by a lung MDT
  • Age 18+, no upper age limit
  • Performance status (PS) - ECOG 0-2. Patients with PS 2 whose general condition is explained by disease can be included at the discretion of the local investigator. Patients with PS 2 as a result of co-morbid conditions will be excluded
  • Patient considered suitable for radical RT
  • Tumour that can be encompassed within a radical RT treatment volume (MLD expected to be <20Gy)

Exclusion Criteria:

  • Patients suitable for standard concurrent CTRT
  • Patients only suitable for radical RT due to PS and co-morbidities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01836692
Other Study ID Numbers  ICMJE 11_DOG07_136
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prof Corinne Faivre-Finn, The Christie NHS Foundation Trust
Original Responsible Party Sally Falk, The Christie NHS Foundation Trust, Dr Corinne Faivre-Finn, Consultant Clinical Oncologist
Current Study Sponsor  ICMJE Prof Corinne Faivre-Finn
Original Study Sponsor  ICMJE Sally Falk
Collaborators  ICMJE
  • Cancer Research UK
  • British Lung Foundation
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • Belfast Health and Social Care Trust
  • The Leeds Teaching Hospitals NHS Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • Royal Marsden NHS Foundation Trust
  • East and North Hertfordshire NHS Trust
Investigators  ICMJE
Principal Investigator: Corinne Faivre-Finn, MD PhD The Christie NHS Foundation Trust
PRS Account The Christie NHS Foundation Trust
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP